Multiple-biomarker Approach for Individualized Treatment of Heart Failure with Preserved Ejection Fraction
Recruiting · NCT06785506 · Observational (researchers observe without assigning treatment) · Lead sponsor: Erasmus Medical Center
View the official record on ClinicalTrials.gov →What this trial is about
The primary objective is to investigate the association between temporal evolutions of blood biomarkers and clinical adverse events, in order to produce a dynamic, individual, and accurate prediction model for patients with HFpEF. Moreover several secondary objectives will be investigated.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age of 18 years or older
- Capable of understanding and signing informed consent
- A diagnosis of HFpEF according to the HFA-PEFF diagnostic algorithm of the ESC or/and a high (90%) probability of HFpEF according to the H2FPEF score, i.e. a score of 6 or higher.
Exclusion criteria
- History of LVEF ≤40%
- Scheduled for surgery or intervention for both coronary and non-coronary indication within 6 months of inclusion
- Impaired renal function, defined as eGFR \< 20 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis at the time of screening
- Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
- COPD Gold stage IV
- Congenital heart disease
- Pregnancy
- Coexistent condition with life expectancy of \<1 year
- Unlikely to appear at all scheduled follow-up visits
- Linguistic barrier
Where it is running
6 locations listed.
- Noordwest Ziekenhuisgroep - Alkmaar, North Holland, Netherlands
- Amsterdam UMC - Amsterdam, North Holland, Netherlands
- OLVG Ziekenhuis - Amsterdam, North Holland, Netherlands
- Franciscus Gasthuis & Vlietland Ziekenhuis - Rotterdam, South Holland, Netherlands
- Erasmus MC - Rotterdam, South Holland, Netherlands
- Ikazia Ziekenhuis - Rotterdam, South Holland, Netherlands